BEUDAMED
    FDA Enforcement Class II Terminated

    EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

    Recall: Z-2497-2021 · Reported September 29, 2021

    Enforcement

    Recall Number
    Z-2497-2021
    Event ID
    88560
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 29, 2021
    Initiation Date
    August 17, 2021
    Classification Date
    September 21, 2021
    Termination Date
    January 12, 2024
    Address
    3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States

    Description

    EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

    Reason

    A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.

    Code Info

    1200148 2500873 2100707 2710983 1500300 1400209 2600505 1300163 1400273 1400248 2700521 2500431 1500310 1200129 2300805 2811029 1500292 2700520 2100743 1500313 2911060

    Distribution

    US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.

    Quantity

    27 globally (21 US)